Trial to Test the Effectiveness of Vibrotactile Stimulation for Lower Limb Spasticity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorWeill Medical College of Cornell University

About this trial

The goal of this clinical trial is to find out if Vibrotactile Stimulation (VTS) can help improve mobility and reduce spasticity (muscle stiffness) in people with lower limb spasticity. The study will also look at how VTS affects walking speed. The main questions it aims to answer are:

* Which areas of the body are the best for applying VTS? * Does VTS help improve walking speed in people with lower limb spasticity?

Participants will:

* Receive 15 minutes of VTS treatment on different parts of the body * Use the VTS device for 60 minutes during supervised lab sessions and at home (at rest and while walking) * Complete a daily log of how much time the device was used for and note any issues or difficulties the participant experience * Complete assessments after the treatment to measure change in mobility * Complete surveys about how comfortable the device is to use

Eligibility criteria

Qualifiers

≥6 months following neurologic diagnosis leading to spasticity

Modified Ashworth Scale (MAS) score of 3 or lower on ankle plantar flexor.

Ability to stand (with or without assistance) and lie supine.

Able to understand and comply with study procedures.

Disqualifiers

Uncontrolled systemic illness or serious medical conditions that could interfere with study procedures.

Previous surgery to treat spasticity in the affected lower limb.

Prior Botulinum Toxin (BoNT) therapy in the target limb within 4 months.

Unstable medication regimens for spasmolysis or muscle relaxation.

Trial design

Treatments tested in this trial

  • Vibrotactile Stimulation (Static Use)
  • Vibrotactile Stimulation (Dynamic Use)
  • Vibrotactile Stimulation (Neurophysiological Mechanism)

Treatment groups

25 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Weill Medical College of Cornell University

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator